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Antibiotics to Decrease Post ERCP Cholangitis

NCT03087656 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-03-06

No results posted yet for this study

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to treat bile duct stones, obstructive jaundice, biliary leaks, and a variety of other conditions.

There is active debate whether antibiotics should be given prophylactically for ERCP outside of high risk indications including primary sclerosing cholangitis. In part this is due to a lack of appropriately powered clinical trials with adequate follow up. The aim will be to assess whether prophylactic antibiotics decrease the rate of post ERCP cholangitis as defined by the Revised Tokyo Criterion.

Conditions

  • Cholangitis

Interventions

DRUG

Ceftriaxone

Intravenous Ceftriaxone will be given during the procedure.

DRUG

Levofloxacin

Oral Levofloxacin will be given for 3 days after the procedure.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • James Buxbaum · University of Southern California Health Science Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2024-02-23
Completion
2024-02-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087656 on ClinicalTrials.gov